The Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.
In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
Reimbursement under the community drugs schemes, including the Long-Term Illness Scheme (LTI), is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.
Liraglutide does not currently have a marketing authorisation for the treatment of Polycystic Ovary Syndrome. If marketing authorisation is granted for an indication covering this illness, the HSE will be open to receiving an application for its reimbursement from the marketing authorisation holder.
Liraglutide marketed as Victoza was approved by the HSE for addition to the Reimbursement List for the treatment of Diabetes. Diabetes is one of the Long-Term Illness conditions for which eligible LTI persons can access their medicines free of charge.
The HSE has advised that it subsequently received an application for the reimbursement of Liraglutide marketed as Saxenda indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients.
On 29 October 2019, in line with agreed processes, the HSE commissioned a full pharmacoeconomic assessment with respect to this indication following the completion by the NCPE of a rapid review.
On 8 July 2020, the NCPE received the applicant’s submission for this assessment and the HTA is currently under way. The application remains under consideration with the HSE and a decision will be made in line with the 2013 Act.
The Long-Term Illness Scheme (LTI) was established under Section 59(3) of the Health Act 1970 (as amended). The conditions covered by the LTI are: acute leukaemia; mental handicap; cerebral palsy; mental illness (in a person under 16); cystic fibrosis; multiple sclerosis; diabetes insipidus; muscular dystrophies; diabetes mellitus; parkinsonism; epilepsy; phenylketonuria; haemophilia; spina bifida; hydrocephalus; and conditions arising from the use of Thalidomide. Under the scheme, patients receive drugs, medicines, and medical and surgical appliances directly related to the treatment of their illness, free of charge.
Polycystic ovary syndrome is not included on the above list and there are no plans to extend the list of conditions covered by the scheme at this time. However, a review of the current eligibility framework, including the basis for existing hospital and medication charges, will be carried out under commitments given in the Sláintecare Implementation Strategy.
For people who are not eligible for the LTI Scheme, there are other arrangements which protect them from excessive medicine costs.
Under the Drug Payment Scheme, no individual or family pays more than €114 a month towards the cost of approved prescribed medicines. The scheme significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.
People who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be entitled to a medical card. In the assessment process, the HSE can take into account medical costs incurred by an individual or a family.
People who are not eligible for a medical card may still be able to avail of a GP visit card, which covers the cost of GP consultations.